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On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 IP (IP Code), which repealed and replaced the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law). The new IP Code entered into effect on January 10, 2017. In this multi-part series, we will address how this new IP Code changes the IP landscape in Turkey. In our second installment of the series, we will examine the changes to the codes relating to industrial designs. In part one, we examined the changes to the codes involving patents and utility models.

Submission of the Description of the Designs

Under the new IP Code, during examination, the submission of the description of an industrial design is optional. This is because the information provided in the description does not affect the scope of the protection of the design. In contrast, the former Decree Law required such a description to be provided during examination. The new IP Code avoids an obligatory requirement for registering a design.

Industrial Designs will be Examined for Novelty

During examination, a design will now be examined for“novelty”. Designs found not to be novel will be ex-officio refused. The former Decree Law did not provide an ex-officio novelty search stage during examination. In fact, novelty could only be questioned through a post-grant opposition or an invalidity action before the IP Courts.

Visible Parts of a Complex Product

According to the IP Code, only the visible parts of a complex product are protectable. However, in order for the visible parts of a complex product to be protected, the visible parts must meet novelty and distinctive character requirements. A design is considered to be novel if before the application date no identical design has been made available to the public anywhere in the world.

A design is understood to have an distinctive character if the overall impression it creates on the informed user is significantly different from the overall impression created on the same user by any design which has been made public (in Turkey or anywhere else in the world) before the application date of the design. In the assessment of the distintiveness, the emphasis of the evaluation will be on the common features of the design; however, the degree of freedom of the designer in developing the design will also be taken into consideration.

Spare Parts of a Complex Product

According to Decree Law, the owner of a registered design could not assert its rights with respect to a visible part of a complex product until three years after the time period after which the design was first made available to the public. The new IP Code introduces a new derogation stating that the this three year period is not be applicable if the protected spare part design is mentioned among the list of “equivalent parts” issued by the Ministry of Science, Industry, and Technology.

Shorter Opposition Period

Under the new IP Code, the post grant-opposition period is now three instead of six months. The reduction from six to three months will reduce the total registration time to less than a year.

Non-Registered Industrial Design Rights

In order for a design to be protected as a “non-registered” design, the design must first be made available to the public in Turkey. The duration of protection for a non-registered design is three years from the date the design was first made available to the public (in Turkey). Interestingly, non-registered design protection is intended to protect fast changing designs which are not intended to be registered for long periods by the design owner. This type of protection will avoid registration costs for the designs for which registration is not preferred. However, the owner of a non-registered design will be requested to evidence of ownership and that the design was first made available to the public in Turkey when enforcing its rights.

Non-registered designs are also protectable without any time limit under the unfair competition provisions of the Turkish Code of Commerce which remain in force. During the next few years, it will be interesting to watch whether the Courts in Turkey will still allow such unfair competition cases after the completion of the 3 year protection period.

Enforcement of Non-Registered Designs

Under the new IP Code, designs are protectable for three years from the date of first public disclosure, if such disclosure was made in Turkey. This protection is available for non-registered designs to prevent the use by third parties of identical or similar non-registered designs. The IP Code also provides a common provision for the compensation of damages arising from intellectual property rights including registered and non-registered designs. As a result, a design holder can ask for material damages which include actual damages and loss of income. The loss of income can be calculated pursuant to one of the three (3) options mentioned in the IP Code, namely, the loss of income of the plaintiff, the income of the defendant or in accordance with an exemplary license fee. Upon request by the plaintiff, the Court can increase the damages for the design holder under specific circumstances. Moreover, the design holder can also seek moral/reputational damages.

Under the IP Code, a design holder can ask the Court to issue a preliminary and/or permanent injunction, compensation, the confiscation/destruction of the infringing goods and the tools and machinery (such as those used for manufacturing the infringing products), the publication of the verdict in a daily newspaper or any similar award.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 (IP Code), which repeals and replaces the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law). The new IP Code went into effect on January 10, 2017. In this multi-part series, we will address how this new law changes the IP landscape in Turkey. The first part of the series will focus on changes to the codes regarding Patents and Utility Models.

Post Grant Opposition

Previously, the only way to contest a patent under Turkish Patent Code was to file a cancellation action before the courts. However, under the new IP Code, third party oppositions against granted patents are now possible. Specifically, the opposition must be filed within six months of the publication of a grant decision. Once filed, the patentee is notified of the opposition by the Turkish Patent and Trademark Institute (TPTI), and invited to submit an opinion regarding the opposition or amend its patent (namely, the claims and/or specification). Although the examination board is yet to be established, the board will serve to examine the opposition and patentee’s opinion and amendments, and ultimately decide whether to invalidate the patent or refuse the opposition. The IP Code and the draft of the Regulation on the Implementation of the IP Code, do not stipulate any oral hearing for the opposition proceedings. Third parties may oppose a patent on the grounds that the:

Subject matter of the invention is not novel / does not involve inventive step / is not susceptible of industrial application;

Subject matter of invention is excluded from patentability;

Invention is not disclosed sufficiently clear and complete;

Invention contains subject-matter which extends beyond the content of the application as filed- the subject-matter of the patent is not patentable;

Invention is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; and

Subject-matter of the patent extends beyond the content of the application as filed.

The examination board will examine the opposition, observations and amendments of the patentee and issue a decision on the revocation/amendment of the patent.

Biotech Patents and Subject Matter Eligible

The provision of the IP Code relating to patentable inventions defines the types of inventions which are not patentable. Specifically, the discovery of any elements of the human body and the human body itself in its natural environment are not patentable. For example, claims directed to human gene sequences or process for cloning a human being will be rejected as being directed to non-patentable subject matter. Unfortunately, claims directed to proteins and antibodies are not specifically addressed. With respect to diagnostic methods, these methods are considered to be non-patentable subject matter in accordance with the European Patent Convention (EPC).

Second Medical Use Patents

The Turkish Supreme Court overruled a 2014 Istanbul IP Court decision which held that the second medical use claims granted by the European Patent Office (EPO) under the European Patent Convention (EPC) 1973 were null and void. The Supreme Court further emphasized that Turkish law does not exclude second medical use inventions from patentability, and acknowledges the protection of second medical use patents validated through the EPC. Unfortunately, the new IP Code is silent with respect to the patentability of second (and further) medical indications of a per se already known substance or composition (second medical use inventions).

Swiss-type claims are not allowable before the EPO for an EP patent application having a filing date or an earliest priority date after 29 January 2011 (G 2/08). However, in practice, the TPTI accepts any type of claims via validation through the EP route without conducting any further examination. Therefore, for effective protection of second medical use patents, it is recommended that applicants proceed through EP validation in Turkey.

Abolition of the Seven-Year Patent System

Under the previous Turkish patent law, a seven year short-term patent could be obtained without an applicant’s having proceeded through substantive examination. The new IP Code mandates that all applicants request substantive examination of their applications. Failure to do so will result in the application being considered to be withdrawn. It is expect that this change will improve the quality of patents and to provide an overall stronger patent framework, particularly for small and medium sized enterprises.

The new IP Code applies to international and national patent applications filed after the enactment of the new IP Code. What this means is that international and national patent applications filed before the enactment of the IP Code will be treated according to the provisions of the Decree Law. It is important to note that should a patentee of a seven year short-term patent wish to convert to a twenty year long term patent through a request of substantive examination, such request will be treated in accordance with the Code in force at the date of the filing of the request.

Utility Model System Re-Adapted

A novelty search will now be required for utility model applications and applicants will have the opportunity to file amendments during the registration proceedings. Although post grant oppositions may be filed against patents, post grant oppositions will not be allowed for utility models. Moreover, the new IP Code stipulates that no utility model certificate will be granted for:

Biotechnological inventions;

Chemical processes or products, or any products or processes obtained therefrom; and

Pharmaceutical processes or products, or any products or processes obtained therefrom.

Employee Inventions System for Universities

Under the new IP Code, any inventions made by scientific staff (including Ph.D. students and non-Ph.D. students) as part of their university employment, belong to the university under certain conditions. This new requirement removes the previous “professor’s privilege”, provided under the Decree Law that provided that researchers and academicians working at universities could automatically own the invention subject to the patent. The new IP Code also states that at least 1/3 of the income generating from use of the patent will belong to the inventor researcher/academician.

Compulsory Licensing

The new IP Code provides new grounds for the granting compulsory licenses. Specifically, the patentee can be requested to grant a compulsory license if the patentee breaches competition such as to block, restrict or destruct the competition in the market. The patentee may also be asked to grant a compulsory license if the use of the patent does not meet the local market needs of the country.

Burden of Proof in Process Patents

Under the previous law, the burden of proof in process patent infringement cases was provided in two Articles. Specifically, the first article, Article 84 of the Decree Law No. 551 stated that where a process patent claimed the manufacture of new products or substances, unless there was proof to the contrary, any product or substance having the same properties (as the product produced by the patented process) were automatically deemed to have been obtained using patented process. Under this situation, the burden of proof was with the person claiming the contrary.

The second article, Article 136, provided that where a process patent claimed the production/preparation of a product, all products possessing the same properties (as the products produced by the patented process) were deemed to have been manufactured by the patented process. A defendant claiming that it manufactured/produced the product without infringing the patented process had the burden of proof.

In the new IP Code, Article 141/2 states that where a process patent claims the production/preparation of a product or a substance, the court may request that the defendant prove that its product (having the same properties as the product produced by the claimed process) has been produced/manufactured without infringing the patented process. Where the patent claims a process for the production/preparation of a new product or substance, all products possessing the same properties as the product produced by the patented process, will be considered to have been produced/manufactured by the patented process. A defendant claiming that it manufactured/produced a product without infringing a patented process will have the burden of proof.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

Familial Mediterranean fever (FMF) is an inherited condition resulting from mutations in the FMF gene and is characterized by recurring episodes of painful inflammation in the abdomen, chest and/or joints. These episodes are often accompanied by fever and sometimes a rash or headache. The FMF gene provides instructions for making a protein called pyrin (also known as marenostrin), which is found in white blood cells.

A Turkish patent issued on October 22, 2007, claiming an isolated gene sequence encoding FMF, nucleic acid probes specific for the normal or mutated FMF gene and a method of detecting the presence or absence of mutations related to FMF an isolated gene.

An invalidity action was instituted against the patent in the Istanbul 1st Court of Intellectual Property (Court). Specifically, the third party filer requested invalidity of all of the issued claims. The Court appointed a panel of three experts (a first panel of experts) to assist in evaluating the patentability of the claims. In invalidity proceedings in Turkey, a panel of experts is hired to assist in evaluating the technical aspects of a patent and to conduct an assessment on novelty and inventive step in light of the documents submitted by the party requesting invalidity. Interestingly, in this proceeding, because the Court was not satisfied with the first panel, a second panel was hired to replace the first panel.

Ultimately, the Court held the Turkish Patent partially invalid. Specifically, the Court held that claims directed to an isolated gene sequence were invalid and claims covering the probe specific for the normal or mutated FMF gene and the primers for amplification were valid. The decision can be appealed to the Supreme Court of Turkey by one or both of the parties. The Supreme Court may maintain or reverse the decision of the Court. If reversed, the Court can issue a new decision or insist that the original decision be maintained. If the Court insists on maintaining the original decision, the case will be referred to the General Council of the Supreme Court which will issue a final decision.

Issues Discussed by the Court

The two main points addressed by the Court were (1) the patentability of isolated genes; and the (2) patentability of a method and probe for detecting nucleic acids under Turkish Patent Law.

Patentability of an isolated gene based under Turkish Patent Law

Interestingly, in this case, the Court and the panel of experts held conflicting views on the patentability of genes. Specifically, the Court held that an isolated gene was not patentable because it existed in nature and, as such, should be classified as a discovery. The Court referred to Decree Law No. 551, Article 6 (reproduced below), in support of its decision that discoveries are not patentable. Additionally, because Turkey is a member of the World Trade Organization (WTO), the Court further held that under TRIPS, Article 27 (reproduced below) certain subject matter could be excluded from being “patentable” in Turkey.

The following, not being inventions by nature, shall remain outside the scope of this Decree-Law:(a) discoveries, scientific theories, mathematical methods;(b) plans, methods and rules for performing mental acts, conducting business activities and playing games;(c) literary and artistic works, scientific works, creations having aesthetic characteristics, computer programs;(d) methods of collecting, arranging, presenting and transmitting information that have no technical features;(e) methods of diagnosis, therapy and surgery applicable to the human or animal body.The provisions in subparagraph (e) of the first paragraph of this Article shall not apply either to the actual products and compositions used in connection with the said methods or to the manufacturing process thereof.

Patents shall not be granted for inventions relating to the following:(a) subject matter contrary to public policy or generally accepted standards of morality;(b) plant and animal varieties or processes for breeding plant or animal varieties that are based mainly on biological factors.

Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

Members may also exclude from patentability:(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

The first panel concluded that the invention was merely a discovery and, as a result, not patentable. In their written opinion to the Court, the second panel disagreed and concluded that biotechnological inventions were patentable. Specifically, the second panel stated that there was nothing in Decree Law No. 551 on the Protection of Patent Rights, Article 6 (see above), regarding the patentability of methods of treatment, second medical use and biotechnological inventions. Moreover, the panel noted that Turkey was a member of the Budapest Treaty for Patents in Microbiological Inventions. Additionally, the panel referred to Decree Law No. 551, Article 46 (reproduced below) to demonstrate that microorganisms and microbiological processes were recognized under Turkish law as patentable inventions. For these reasons, the panel argued that Turkish Patent Law allowed patent protection for elements existing in nature.

The description shall be written in sufficiently explicit and comprehensive terms for a person skilled in the technical field concerned to carry out the invention.Where the invention relates to a microbiological process and the related microorganism is not accessible to interested parties, the description shall be deemed to meet the requirements specified in the first paragraph of this Article if the following conditions are fulfilled:(a) the description contains information regarding the characteristics of the microorganism;(b) the applicant has deposited, no later than on the filing date of the application, a culture of the microorganism with an authorized institution established in accordance with international conventions.The said institution shall be mentioned in the publication provided for in the second paragraph of Article 55.

The panel cited Directive 98/44/EC (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of biotechnological inventions, reproduced below) and argued that genes isolated using novel and technical processes were patentable (Note: Turkey is not a member of the European Union (It is a candidate country). As a result, this directive is not applicable in Turkey.). Additionally, in the panel’s opinion, a gene isolated from its natural environment for the first time and having a technical effect might be patentable, even if identical to a gene existing in nature. Therefore, according to the panel, biotechnological inventions are patentable.

The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

The Court invited the second panel to be heard in the hearing. During the hearing, two of the experts changed their written opinion and stated that gene sequences should be accepted as a discovery. As a result, despite the favorable written opinion of the panel, the Court held that a gene sequence is not patentable.

Patentability of a method and probe for detecting nucleic acids

The Court held that probes and methods for detecting nucleic acids were patentable. Specifically, the Court‘s reasoning was as follows. A probe can only be produced when a mutated gene sequence is known. It is not possible to identify or detect a mutated gene with any probe production processes without knowing the gene sequence. Therefore, the novelty of a probe does not depend on its technique of production but on the sequence of the mutated gene. Since a mutated gene sequence is unique, the probe is patentable, even though probes are simply the chemical copy of the mutated gene and a molecule. As a result, the Court held that the claimed probe and method for detecting nucleic acids claimed in the patent were novel and met the requirement of inventive step.

Conclusion

As mentioned previously, the Court held the Turkish Patent invalid. This decision can be appealed to the Supreme Court.

A new draft Turkish IP Code has been published and is expected to be enacted in the very near future. According to the draft, gene sequences are not patentable if the discovery of such sequences is simply the result of a “simply discovery”. In other words, new gene sequences that are not isolated through novel and inventive methods will not be patentable in Turkey.

Please continue to watch the BRIC Wall Blog for updates on this important case and the expected changes in the Turkish IP Code.

This post was written by Lisa Mueller and Himani Nadgauda of Michael Best & Friedrich LLP, and Okan Can and Muazzez Koruturk of Deris Attorneys at Law Partnership.

Informa Life Sciences will be hosting a conference entitled, “Biosimilars and Biotech: MENA Conference” in Istanbul, Turkey on November 18th-19th. I will be presenting during this conference on the topic of global biosimilar development as well as providing an update on biosimilars in the U.S.

The conference will examine a number of topics that may be of interest to BRIC Wall Blog readers, including biosimilar development in Turkey and the Middle East, as well as an interesting session on understanding and accessing biosimilars in Iran.

I will be providing updates to BRIC Wall readers on topics from the conference beginning tomorrow.

If any of our readers are attending the conference, please stop by and say hello.

1. India is considering a proposal to amend Rule 122(E) of the Drugs and Cosmetics Act to include products with new drug delivery systems (such as time-release, modified release, etc.) under the “new drug” category. From a practical standpoint what this means is that drug makers who launch differentiated products using such new drug delivery systems may not be able to bypass clinical trials and additional regulatory monitoring. This may delay launches and increase drug development costs for those pharmaceutical companies using these new delivery systems. To learn more, click here.

2. An interesting article published in the Journal of Market Access & Health Policy in November 2013 compared the performance of new molecule (NM) launches in the United States (US), European Union (EU) and Turkey between 2007-2013. The article reports that of the 183 NMs launched in the EU, US or both, only 44 (24%) were launched in Turkey. Of these 44 NMs, 34 received official reimbursement approval. Additionally, the difference in launch dates between the EU or US and Turkey was a mean delay of 821 days (2.25 years). The article can be found here: MTURKEYUSEU

In Turkey, medicinal products, including biologics and biosimilars, can only be marketed once a marketing authorization has been issued by the General Directorate of Pharmaceuticals and Pharmacy of the Ministry of Health (MOH). In order to understand the marketing authorization process in Turkey, it is important to understand how certain terms are defined by the MOH. Important terms include:

1. “Medicinal products” are any natural and/or synthetic active substances or combination of substances (including biological drugs and biosimilar drugs) administered to a human for the purpose of treating and/or preventing disease, making a diagnosis, or correcting or modifying a physiological function.

3. An “active substance” is any pharmacological active substance used in medicinal products.

4. A “registered medicinal product for human use” is a medicinal product, approved by the MOH, which is presented to the market in ready form, in special packaging, with a specific name.

5. A “biological drug” is a product requiring manufacturing and control procedures as well as a combination of physicochemical biological tests to determine the quality of an active substance and is produced or extracted from a biological source. Examples of a “biological drug” include: (a) immunological products; (b) blood products; (c) products obtained through recombinant DNA technology in prokaryotic and eukaryotic cells, the controlled expression of genes coding for biologically active proteins, including transformed mammal cells, hybridoma and monoclonal antibody methods; (d) advanced medical treatment products which concern manufacturing processes involving biological molecules in which the active substance is produced in whole or in part by means of gene transfer and/or genetically modifying cells for the purpose of advanced biological and/or medical treatment; and (e) reagents from which the active substance is not directly derived, namely, products derived from a culture medium, bovine fetus serum, additives, chromatography, etc.

6. A “biosimilar drug” or “biosimilar product” is a medicinal product which demonstrates similarity to a designated or retained biological (medicinal) reference product (biological reference product) in terms of quality, safety and efficacy. The active substance of a biosimilar drug or product is similar to a biological reference drug. Generally, a biosimilar drug and a biological reference product are used at the same strength to treat the same disease. Typically, the only difference between a biosimilar drug and a biological reference product is the trade name, appearance and packaging.

7. A “designated or retained biological (medicinal) reference product” or “biological reference product” is a biological drug for which a complete application, including administrative, quality, pre-clinical and clinical data, has been made and approved by a regulatory authority outside of Turkey (such as the FDA or EMA).

Biologics

In Turkey, to obtain approval of a new biological product, an applicant must submit a “full” application to the MOH. A “full” application involves providing sufficient information to demonstrate the quality, safety and efficacy of the new biological product for the indications requested. As will be discussed in more detail below, this information includes complete and detailed information regarding the biological product, pre-clinical studies {including toxicity studies, pharmacokinetic studies (PK studies), pharmacodynamic studies (PD studies), local tolerance studies, etc.}, phase I, II and III clinical studies (in all indications for which approval is sought), as well as a risk management plan. The phase I, II and III clinical trials (for either a biological or a biosimilar) can be conducted in a country other than Turkey provided that the clinical trials have been approved by the regulatory authority of that country (such as the FDA, EMA, etc.).

Some of the information that an applicant must submit to the MOH when seeking approval for a new biological product includes:

1. The name, permanent address, e-mail, telephone and fax number of the applicant;

2. The name, permanent address, telephone and fax number of the manufacturer;

3. The name of the medicinal product;

4. The quantitative and qualitative particulars of the constituents of the medicinal product using common terminology (except for the empirical chemical formula) and its international non-proprietary name (INN) as recommended by the World Health Organization (where applicable);

5. A description of the manufacturing method;

6. A description of the therapeutic indications, contraindications, adverse reactions, special precautions for use (including descriptions involving use during pregnancy and lactation, interaction with other drugs and other forms of interactions, symptoms, emergency procedures and antidotes in the event of an overdose, special warnings, effects on the ability to drive and use machines, etc.);

7. The dosage, pharmaceutical form, method and route of administration, shelf life and amount contained in a package;

8. An indication of the disposal method for waste products (after consideration of the storage conditions of the medicinal product, its administration to patients and the potential risks presented by the medicinal product to the environment);

9. A description of the control methods used by the manufacturer (including quantitative and qualitative analysis of the constituents and finished products, sterility tests, pyrogen substances, tests for measuring the presence of heavy metals, stability tests, biological and toxicity tests, controls conducted during the intermediate phase of manufacturing, etc.);

12. For new medicinal products that are to be imported (rather than manufactured in Turkey), a summary of the product characteristics drafted by the originating company and an indication of the term of validity (there are three different terms of “validity”, specifically, (a) the “proposed” shelf life of the product; (b) the shelf life of the product after the packaging has been opened; and (c) the shelf life of the product after dilution), package insert and a mock-up of the proposed packaging;

13. For new medicinal products that are to be imported, a document drafted by the originating company, along with a Turkish translation thereof, indicating that the real or legal person importing the product is the sole authorized representative for the manufacture, registration and sale of the product in question or a co-marketing representative, where applicable;

14. For new medicinal products for which the manufacturing of the product is licensed to a third party, a document drafted by the originating company along with a Turkish translation thereof, indicating that the real or legal person manufacturing the product is the sole authorized representative for the manufacture, registration and sale of the product in question or a co-marketing manufacturer, where applicable;

15. A good manufacturing practice (GMP) document approved by the MOH or a competent authority of a relevant country (such as the FDA, EMA, etc.), indicating that the manufacturer will manufacture the product in accordance with GMP rules;

16. In the event that the applicant is not the manufacturer of the new biological product, a notarized toll manufacturing agreement signed with the manufacturer (the agreement must contain the conditions specified in the Regulation on Manufacturing Sites of Medicinal Products for Human Use as published in the Official Gazette dated 23/10/2003, no. 25268);

17. A list of other countries where an application for the biological product has been submitted for approval by a competent authority (such as the FDA, EMA, etc.) and a certified copy of a Pharmaceutical Product Certificate issued by such authority in any other country or countries where the product has been approved and introduced into the market;

18. Description of the potential risks to be imposed on the environment by the new biological product upon consideration of the provision of the Regulation on Radiation Safety, enforced by the Decision dated 24/07/1985, no. 85/9727 of the Council of Ministers, the Regulation on the Safe Transportation of Radioactive Substances, published in the Official Gazette dated 10/09/1997, no. 23106, the Regulation on Radiation Safety published in the official Gazette dated 24/03/20002, no. 23999, and the Regulation on the Waste Formed in the Use of Radioactive Substances, published in the Official Gazette dated 02/09/2004, no. 25571;

19. A summary of the product characteristics as specified in the legislationpertaining to the packaging and labeling and a package insert prepared accordingly, mock-ups of the immediate outer-packaging including the size and design to be used in the market, the original summary of the product characteristics approved by competent authorities in other countries for products imported or manufactured under a license, including the product insert and package mock-ups; and

20. A list of the countries in which a biological product has been rejected, recalled or suspended by a competent authority or in which the applicant has withdrawn the product, including specific and detailed information regarding the rejection, recall, suspension or withdrawal and the steps taken by the applicant to rectify the problem.

Biosimilars

In Turkey, to obtain approval of a “biosimilar product,” an applicant must submit an “abridged” application to the MOH. The “abridged” application must demonstrate that there are no significant differences in terms of the quality, safety or efficacy between the biosimilar product and a biological reference product. In addition, a sponsor of a biosimilar product must comply with the requirements of Annex I of the Turkish Regulation for Approval of Human Medicinal Products, the technical requirements of the European Pharmacopeia monographs and any additional general requirements related to biosimilar products described in the guidelines of the Committee for Human Medicinal Products (CHMP) and the International Committee for Harmonisation (ICH).

To demonstrate the “quality” of the biosimilar product, the “abridged” application must include complete and detailed information regarding the biosimilar product, including head-to-head comparability studies with the biological reference product. For example, a biosimilar applicant must provide (1) data demonstrating that the active substance of the biosimilar product exhibits molecular and biological similarity to the active substance of the biological reference product; (2) biological activity, immunochemical properties and physicochemical studies; (3) purity and impurity studies, including an impurity profile; (4) stability data; (5) in vitro dissolution studies; and (6) data demonstrating that the pharmaceutical form, strength and route of administration of the biosimilar product and the biological reference product are the same (if they are not the same, then additional data will need to be presented to show comparability).

In addition, in order to demonstrate safety and efficacy of the biosimilar product, an “abridged” application will need to provide data from pre-clinical and clinical studies. Specifically, with respect to data from pre-clinical studies, an applicant must provide in vivo data showing the comparability of the biosimilar product and the biological reference product with respect to: (1) at least one repeat dose toxicity study (up to four weeks); (2) local tolerance;and (3) PK and PD studies.

Finally, a biosimilar applicant will need to present comparability data from clinical studies. Specifically, a biosimilar applicant will need to present data from phase I PK and PD studies (the PK and PD studies can be combined provided that the PK/PD relationship is characterized) as well as phase III studies (for each indication for which approval is sought). No phase II clinical trials are required. The clinical trial data submitted can be data from clinical trials conducted outside of Turkey provided that the clinical studies were done with the approval from a competent authority (such as the FDA, EMA, etc.) and are comparative with the biological reference product. In addition, a risk management plan will also be required.

Data Exclusivity

In Turkey, a biosimilar product cannot be marketed at any point during the period of data exclusivity for a biological reference product. However, according to the Guidelines on Biosimilar Medicinal Products in Turkey, biosimilar products are exempt from the data exclusivity period if “additional” studies, which are not required to be submitted for the biological product, are submitted to the MOH for approval. Interestingly, the regulations are silent as to the type of “additional” studies that would be accepted by the MOH.

In many countries, the periods of patent exclusivity and regulatory data exclusivity are completely independent and separate from each another. However, in Turkey, this is not the case. In Turkey, the period of data exclusivity is tied to the term of any issued Turkish patent having claims that encompass the active substance of the biological reference product. Specifically, the data exclusivity period for a biological reference product is 6 years from the date of first registration of the product in the European Customs Union {which comprises the member states of the European Union (such as Great Britain, Germany, France, Italy, etc.) as well as some other non-European Union countries (such as Turkey)}. However, this 6 year data exclusivity period is limited to the term of any issued Turkish patent having claims that encompass the active substance of the biological reference product. Specific examples of how the data exclusivity period is calculated are provided below.

Example 1: A biological reference product receives marketing approval in Germany in August 2013, which is the date of first marketing approval (date of registration) for the product in any European Customs Union (ECU) country. Marketing approval for the product is granted by the MOH in Turkey in December 2013. A patent covering the biological reference product (a humanized antibody) expires in February 2020 in Turkey. Under this scenario, data exclusivity would be available for the biological reference product in Turkey until August 2019.

Example 2: A biological reference product receives marketing approval in the Netherlands in August 2011, which is the date of first marketing approval (date of registration) for the product in any ECU country. Marketing approval for the product is granted by the MOH in Turkey in August 2013. A patent covering the biological reference product (a humanized antibody) expired in March 2012 in Turkey. Under this scenario, no data exclusivity would be available for the biological reference product in Turkey.

Example 3: A biological reference product receives marketing approval in Great Britain in August 2013, which is the date of first marketing approval (date of registration) for the product in any ECU country. Marketing approval for the product is granted by the MOH in Turkey in December 2013. A patent covering the biological reference product (a humanized antibody) expires in October 2016 in Turkey. Under this scenario, data exclusivity would be available for the biological reference product in Turkey until October 2016.

Biosimilars in Turkey

To date, two biosimilars have been approved by the MOH in Turkey. The first is “Leucostim” (the licensee of which is Dem İlaç, a Turkish pharmaceutical company, and the manufacturer is DONG-A PHARM. CO., LTD., a South Korean pharmaceutical company) which contains the active substance filgrastim. The second is “Epobel” (the licensee is Nobel İlaç, a Turkish pharmaceutical company, and the manufacturer is STADA Arzneimittel AG, a German pharmaceutical company) which contains the active substance epoetin zeta.